Bioimpedance Spectroscopy Compared to CardioMEMS™

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-07

Study Completion Date

2018-10-09

Brief Summary

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Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.

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Detailed Description

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This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.

Conditions

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NYHA Class III Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Patient:

1. has an CardioMEMs device implanted
2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
3. is able to give informed consent

Exclusion Criteria

Patient:

1. has pacemaker/ICD
2. is pregnant or breastfeeding
3. is an amputee
4. has been diagnosed with multiple medical conditions that would make participation burdensome
5. not able to co-operate with impedance measurements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No